The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.

Further study details as provided by Adelaide Hebert, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit [ Time Frame: 6 to 8 days after treatment ]

Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.

Secondary Outcome Measures:

Clinical Response at Follow up as Assessed by a Rating Scale [ Time Frame: 6 to 8 days after treatment ]

Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true "clinical success" while all others were considered a "clinical failure." Patients were classified with an outcome of "unable to determine" if they missed their follow-up visit or refused clinical examination.

Microbiologic Response at Follow up as Assessed by a Rating Scale [ Time Frame: 6 to 8 days after treatment ]

Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a "microbiological success" while all others were considered "microbiological failure."

Number of Participants Who Were a Therapeutic Success [ Time Frame: 6 to 8 days after treatment ]

Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a "clinical success" and a "microbiological success" were deemed a "therapeutic success," and all others were deemed "therapeutic failures."

Erythema (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Erythema (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Purulence (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Purulence (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Crusting (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Crusting (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Tissue Warmth (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Pain (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Pain (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]

Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

Wound Size at Baseline [ Time Frame: baseline ]

Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.

Wound Size at Follow up [ Time Frame: 6 to 8 days after treatment ]

Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.

Number of Participants Reporting Any Adverse Event (AE) [ Time Frame: baseline to 6 to 8 days after treatment ]

AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.

Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.

Exclusion Criteria:

Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours.

Subject who has been enrolled in a clinical trial within the last 30 days.

Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated.

Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator

Subjects who have taken oral antibiotics within the last 7 days.

Subjects with known sensitivity to the study medication.

The subject is pregnant or breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126268

Locations

United States, Texas

Houston Medical Center Building

Houston, Texas, United States, 77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

GlaxoSmithKline

Investigators

Principal Investigator:

Adelaide A Hebert, M.D.

University of Texas Health Science Center at Houston Department of Dermatology